COVID-19EvaLongCovidNCT05107271
Evaluation of Long Haul COVID-19 and Vaccine Immunogenicity in Patients With Liver Disease
An observational study of COVID-19 and Chronic Liver Failure, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The project is essential to understand the impact of the COVID-19 pandemic in patients with Chronic Liver Disease (CLD). The impact has been felt due to direct risk of COVID infection in self, or in caregivers, lack of access to services during lockdown, interruptions in transplant listing and waitlist mortality. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19, Chronic Liver Failure, Cirrhosis, Liver
- What is being tested?
- COVID-19 serosurvey
- Type of treatment
- Vaccines
- How many people
- 252 participants
- Where
- 1 siteIndia
- Study dates
- 15 Nov 2021to 15 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients with Chronic Liver Disease or those who are post LT recipients who are attached to the inpatient, outpatient, and telehealth services of the Department of Hepatology, PGIMER Chandigarh will be screened for inclusion
Who may be able to join
- The person is between the ages of 18-75 years at the time of signing the informed consent form.
- Individual has chronic liver disease of any etiology and is attached to the Hepatology services of the PGIMER, Chandigarh.
- Individual has had a positive SARS-COV-02 test (PCR) within the last 12 months or has been diagnosed presumptive positive and has been treated for COVID-19 within the last 12 months.
- Individual has not fully recovered from COVID-19 in weeks or months despite a negative Sars-COV-02 test and has been diagnosed with Post COVID-19 syndrome.
- Individual is experiencing 2 or more symptoms for over 12 weeks either continually or intermittently with relapses not experienced pre-illness, that interferes with normal daily activities. Symptoms must be new symptoms, or dramatic worsening of symptoms i.e., subject did not have symptoms, and had not sought medical treatment for the symptoms prior to COVID-19, or the symptoms are dramatically worse (in severity and frequency).
- Extreme fatigue - feeling overtired with low energy and a strong desire to sleep.
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- Shortness of breath - (dyspnea) a feeling of being winded, difficulty in breathing, or a hunger for air.
- Cough - hacking, or dry barking sound lingering dry or wet.
- Brain fog -a diminished mental capacity marked by the inability to concentrate or to think or reason clearly that interferes with daily activities.
- Headache - Sharp or dull reoccurring or intermittent that were not present pre-illness.
- Body aches - muscle soreness or generalized achiness throughout the body.
- Joint pain - pain in the joints due to inflammation not experienced before illness.
- Chest pain - (angina) feeling pressure, fullness, or tightness in your chest
- Sleep issues - any sleep disturbances in sleep quality that makes sleep see inadequate or unrefreshing like insomnia or hypersomnia.
- Loss of Taste/Smell - Diminished sense of taste or smell.
Who cannot join
- Subject is unable to provide informed consent or to comply with study requirements.
- Subject has currently been diagnosed with active COVID-19 disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Assessment of Intermediate and Long-term Sequelae of COVID-19 Infection and Immunological Correlates of Protection Induced by COVID-19 Vaccines in Patients With Liver Disease: A Prospective Cohort Study.
The project is essential to understand the impact of the COVID-19 pandemic in patients with Chronic Liver Disease (CLD).
The impact has been felt due to direct risk of COVID infection in self, or in caregivers, lack of access to services during lockdown, interruptions in transplant listing and waitlist mortality. Briefly, the following points will be focused during the study.
- Long haul COVID-19 related symptoms.
- Impact on health and delay in interventions or drug therapy due to interruption of physical outpatient services.
- Impact on emergency admissions due to refractory ascites, new decompensation, variceal bleeding etc
- Impact on delayed transplant listing and waitlist mortality
- Impact on post-transplant patients with lack of access to drug monitoring/ physical OPD
- Impact on delay in interventions due to hepatobiliary malignancy.
- Effects of COVID-19 infection, vaccination (single dose, two doses) and no vaccination and protective antibody levels in patients with chronic liver disease and post-transplant recipients.
- Determination of dose protocol and need for booster vaccination in patients with CLD and post liver transplant recipients.
Read the detailed description
- The novel coronavirus 2019 (COVID-19) disease, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has resulted in a devastating global pandemic, with 179,686,071confirmed COVID-19 cases, which include 3,899,172 deaths reported by the World Health Organization1 as of June 25, 2021. As of June 23, 2021, 2,624,733,776 doses of vaccine have been administered globally. COVID-19 has been reported as an air- and surface-borne contagious disease with features of viral pneumonia (fever, cough, lymphopenia, prothrombotic tendency, ground glass opacities on chest radiology) and hypoxemia.
- In addition, alterations in liver chemistries have been reported in patients with and without liver disease, with some reports of increasing severity, complication, and new decompensation, while others refute this possibility. Liver chemistry changes are more likely in those with severe disease and those who have received multiple therapies, requiring high flow oxygen or invasive ventilation.
- Long-term prospective follow-up studies on persistent symptoms, lung function, physical, and psychological problems of discharged patients with cirrhosis, liver failure or liver transplant recipients are urgently required.
- Health care professionals require predictive models of severity of disease and assess the impact of the COVID-19 pandemic on the health of patients with chronic liver disease (CLD), access to care, specialty interventions like endoscopy, and transplantation.
- In addition, the association between liver chemistries, need for invasive ventilation and COVID-19-associated hospital deaths remains controversial and despite availability of breakthrough vaccines, the pandemic is likely to continue claiming more lives.7 Given the heterogenous clinical presentation, the spectrum of liver involvement varies from altered liver chemistry in patients without underlying liver disease to progressive decompensation in patients with cirrhosis.
- Differential access to COVID-19 care may affect outcomes in patients with CLD. Access to care in India may be affected, for example, by age, region of origin, gender, economic status, disability, homelessness, language, digital accessibility, and social factors influencing attitudes to modern medicine. COVID care models deploy multidisciplinary telemedicine clinics to assess physical and mental health symptoms and to conduct appropriate investigations by calling patients for physical consultation, there has been a barrier to access to care and interventions over the course of the COVID-19 pandemic in India.
- Patients have suffered increased waitlist mortality due to reduction in the access to affordable transplant and redistribution of priority resources to the COVID-19 effort. Patients who are liver transplant (LT) recipients have also suffered from lack of access to follow up due to logistic concerns and travel restrictions. The incidence of COVID-19 infection and outcomes in this subgroup is still unknown. This requires data and policy making at the National level based on serosurveys and vaccination success in our CLD population.
- Patients with chronic liver disease who have suffered from COVID-19 need access to rehabilitation services, with an integrated, multidisciplinary service, based on local need and resources. A range of specialists should be available, especially for expertise in treating fatigue and respiratory symptoms (including breathlessness); additional expertise may be sourced depending on the age and symptoms of the person. The incidence of post COVID-19 fungal sepsis in patients of CLD and LT recipients is another point of concern, and data regarding this secondary effect in our patient cohort is still unknown.
- A major gap in delivery of care is the disruption of the seamless referral pathways between primary care and tertiary level centres. Due to the digital divide between urban and rural sectors, the access to routine services like endoscopy, preventive health care checks, rehabilitation services, transplantation services, endoscopy and interventional radiology procedures and mental health care in our patient cohort has been noted but not systematically evaluated.
- Lastly, about 10% of patients with COVID-19 infection may suffer persistent symptoms, and resulted in a large cohort of individuals with long haul COVID symptoms. The effect of COVID-19 on health care systems and society will be noted for years to come, and a systemic study on the burden of the problem needs to be undertaken to formulate appropriate health care policy.
- Conditions
- COVID-19, Chronic Liver Failure, Cirrhosis, Liver, Portal Hypertension, Liver Transplant Disorder
- Being tested
- COVID-19 serosurvey
- Medical subject headings
- COVID-19, End Stage Liver Disease, Liver Cirrhosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 serosurveyDiagnostic test
COVID-19 related antibody testing to assess immunogenicity of COVID-19 vaccines or post natural infection acquired immunity
| Study group | Role | What they receive |
|---|---|---|
| Chronic Liver Disease | Not described Receives: Diagnostic Test: COVID-19 serosurvey | |
| Post Liver Transplantation | Not described Receives: Diagnostic Test: COVID-19 serosurvey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long haul COVID-19 related symptoms
'Long-COVID-19' describes the long duration symptoms that patients who have recovered from COVID-19 continue to experience even in their post-recovery phase
Measured: 1 year
Immunogenicity of vaccine
Effects of COVID-19 infection, vaccination (single dose, two doses) and no vaccination and protective antibody levels in patients with chronic liver disease and post-transplant recipients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start15 Nov 2021
- Primary completion15 Dec 2022
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhumita Premkumar, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Virendra Singh, MD DM, Study chair, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107271
- Sponsor's protocol ID
- 2021-5859
- Acronym
- EvaLongCovid
- Status last verified
- Jun 2025
- First submitted
- 3 Nov 2021
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment of Intermediate and Long-term Sequelae of COVID-19 Infection and Immunological Correlates of Protection Induced by COVID-19 Vaccines in Patients With Liver Disease: A Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT05107271
- Acronym / sponsor ID
- EvaLongCovid / 2021-5859
- Conditions
- COVID-19, Chronic Liver Failure, Cirrhosis, Liver, Portal Hypertension, Liver Transplant Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project is essential to understand the impact of the COVID-19 pandemic in patients with Chronic Liver Disease (CLD).
The impact has been felt due to direct risk of COVID infection in self, or in caregivers, lack of access to services during lockdown, interruptions in transplant listing and waitlist mortality. Briefly, the following points will be focused during the study.
- Long haul COVID-19 related symptoms.
- Impact on health and delay in interventions or drug therapy due to interruption of physical outpatient services.
- Impact on emergency admissions due to refractory ascites, new decompensation, variceal bleeding etc
- Impact on delayed transplant listing and waitlist mortality
- Impact on post-transplant patients with lack of access to drug monitoring/ physical OPD
- Impact on delay in interventions due to hepatobiliary malignancy.
- Effects of COVID-19 infection, vaccination (single dose, two doses) and no vaccination and protective antibody levels in patients with chronic liver disease and post-transplant recipients.
- Determination of dose protocol and need for booster vaccination in patients with CLD and post liver transplant recipients.
Detailed description
- The novel coronavirus 2019 (COVID-19) disease, caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), has resulted in a devastating global pandemic, with 179,686,071confirmed COVID-19 cases, which include 3,899,172 deaths reported by the World Health Organization1 as of June 25, 2021. As of June 23, 2021, 2,624,733,776 doses of vaccine have been administered globally. COVID-19 has been reported as an air- and surface-borne contagious disease with features of viral pneumonia (fever, cough, lymphopenia, prothrombotic tendency, ground glass opacities on chest radiology) and hypoxemia.
- In addition, alterations in liver chemistries have been reported in patients with and without liver disease, with some reports of increasing severity, complication, and new decompensation, while others refute this possibility. Liver chemistry changes are more likely in those with severe disease and those who have received multiple therapies, requiring high flow oxygen or invasive ventilation.
- Long-term prospective follow-up studies on persistent symptoms, lung function, physical, and psychological problems of discharged patients with cirrhosis, liver failure or liver transplant recipients are urgently required.
- Health care professionals require predictive models of severity of disease and assess the impact of the COVID-19 pandemic on the health of patients with chronic liver disease (CLD), access to care, specialty interventions like endoscopy, and transplantation.
- In addition, the association between liver chemistries, need for invasive ventilation and COVID-19-associated hospital deaths remains controversial and despite availability of breakthrough vaccines, the pandemic is likely to continue claiming more lives.7 Given the heterogenous clinical presentation, the spectrum of liver involvement varies from altered liver chemistry in patients without underlying liver disease to progressive decompensation in patients with cirrhosis.
- Differential access to COVID-19 care may affect outcomes in patients with CLD. Access to care in India may be affected, for example, by age, region of origin, gender, economic status, disability, homelessness, language, digital accessibility, and social factors influencing attitudes to modern medicine. COVID care models deploy multidisciplinary telemedicine clinics to assess physical and mental health symptoms and to conduct appropriate investigations by calling patients for physical consultation, there has been a barrier to access to care and interventions over the course of the COVID-19 pandemic in India.
- Patients have suffered increased waitlist mortality due to reduction in the access to affordable transplant and redistribution of priority resources to the COVID-19 effort. Patients who are liver transplant (LT) recipients have also suffered from lack of access to follow up due to logistic concerns and travel restrictions. The incidence of COVID-19 infection and outcomes in this subgroup is still unknown. This requires data and policy making at the National level based on serosurveys and vaccination success in our CLD population.
- Patients with chronic liver disease who have suffered from COVID-19 need access to rehabilitation services, with an integrated, multidisciplinary service, based on local need and resources. A range of specialists should be available, especially for expertise in treating fatigue and respiratory symptoms (including breathlessness); additional expertise may be sourced depending on the age and symptoms of the person. The incidence of post COVID-19 fungal sepsis in patients of CLD and LT recipients is another point of concern, and data regarding this secondary effect in our patient cohort is still unknown.
- A major gap in delivery of care is the disruption of the seamless referral pathways between primary care and tertiary level centres. Due to the digital divide between urban and rural sectors, the access to routine services like endoscopy, preventive health care checks, rehabilitation services, transplantation services, endoscopy and interventional radiology procedures and mental health care in our patient cohort has been noted but not systematically evaluated.
- Lastly, about 10% of patients with COVID-19 infection may suffer persistent symptoms, and resulted in a large cohort of individuals with long haul COVID symptoms. The effect of COVID-19 on health care systems and society will be noted for years to come, and a systemic study on the burden of the problem needs to be undertaken to formulate appropriate health care policy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Liver Disease | – | Diagnostic Test: COVID-19 serosurvey |
| Post Liver Transplantation | – | Diagnostic Test: COVID-19 serosurvey |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with Chronic Liver Disease or those who are post LT recipients who are attached to the inpatient, outpatient, and telehealth services of the Department of Hepatology, PGIMER Chandigarh will be screened for inclusion
Key inclusion criteria (15 listed)
- The person is between the ages of 18-75 years at the time of signing the informed consent form.
- Individual has chronic liver disease of any etiology and is attached to the Hepatology services of the PGIMER, Chandigarh.
- Individual has had a positive SARS-COV-02 test (PCR) within the last 12 months or has been diagnosed presumptive positive and has been treated for COVID-19 within the last 12 months.
- Individual has not fully recovered from COVID-19 in weeks or months despite a negative Sars-COV-02 test and has been diagnosed with Post COVID-19 syndrome.
- Individual is experiencing 2 or more symptoms for over 12 weeks either continually or intermittently with relapses not experienced pre-illness, that interferes with normal daily activities. Symptoms must be new symptoms, or dramatic worsening of symptoms i.e., subject did not have symptoms, and had not sought medical treatment for the symptoms prior to COVID-19, or the symptoms are dramatically worse (in severity and frequency).
Key exclusion criteria (2 listed)
- Subject is unable to provide informed consent or to comply with study requirements.
- Subject has currently been diagnosed with active COVID-19 disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 serosurveyCOVID-19 related antibody testing to assess immunogenicity of COVID-19 vaccines or post natural infection acquired immunity | Diagnostic test | Chronic Liver Disease, Post Liver Transplantation |
Primary outcome
Long haul COVID-19 related symptoms
Time frame: 1 year
'Long-COVID-19' describes the long duration symptoms that patients who have recovered from COVID-19 continue to experience even in their post-recovery phase
Immunogenicity of vaccine
Time frame: 1 year
Effects of COVID-19 infection, vaccination (single dose, two doses) and no vaccination and protective antibody levels in patients with chronic liver disease and post-transplant recipients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virendra Singh, MD DM study chair
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Chronic Liver Failure, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long haul COVID-19 related symptoms (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.